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Dehydrated Alcohol Injection, USP
Dehydrated Alcohol Injection, USP is a Sclerosing agent / Ablative agent Small molecule drug developed by Ablative Solutions, Inc.. It is currently in Phase 3 development for Percutaneous ablation of hepatocellular carcinoma, Ablation of benign and malignant liver lesions. Also known as: Alcohol.
Dehydrated alcohol causes tissue ablation and coagulation necrosis through protein denaturation and cellular dehydration when injected directly into target tissue.
Dehydrated alcohol causes tissue ablation and coagulation necrosis through protein denaturation and cellular dehydration when injected directly into target tissue. Used for Percutaneous ablation of hepatocellular carcinoma, Ablation of benign and malignant liver lesions.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Dehydrated Alcohol Injection, USP |
|---|---|
| Also known as | Alcohol |
| Sponsor | Ablative Solutions, Inc. |
| Drug class | Sclerosing agent / Ablative agent |
| Modality | Small molecule |
| Therapeutic area | Oncology / Interventional Radiology |
| Phase | Phase 3 |
Mechanism of action
Dehydrated (absolute) alcohol is a sclerosing and ablative agent that works by extracting water from cells and denaturing proteins, leading to immediate coagulation necrosis and tissue destruction. When injected into pathological tissue or lesions, it creates a localized zone of cell death and fibrosis. This mechanism is used for percutaneous ablation of benign and malignant lesions, particularly in the liver and other organs.
Approved indications
- Percutaneous ablation of hepatocellular carcinoma
- Ablation of benign and malignant liver lesions
Common side effects
- Pain at injection site
- Hepatic dysfunction
- Fever
- Infection
- Bleeding
Key clinical trials
- Sublingual Atropine Bioequivalence by Route of Administration (SABER) (PHASE1)
- Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy (PHASE3)
- Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR) (PHASE3)
- PHASE 1 SARS-COV-2-Spike-Ferritin-Nanoparticle (SpFN) Vaccine With ALFQ Adjuvant for Prevention of COVID-19 (PHASE1)
- Genomic Effects of Glucocorticoids in Patients With Systemic Lupus Erythematosus (EARLY_PHASE1)
- Study to Evaluate the Safety of a New Oxime, MMB4 DIMETHANESULFONATE (DMS) (PHASE1)
- Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Minocin (Minocycline) for Injection in Healthy Adults (PHASE1)
- TARGET BP I Clinical Trial (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Dehydrated Alcohol Injection, USP CI brief — competitive landscape report
- Dehydrated Alcohol Injection, USP updates RSS · CI watch RSS
- Ablative Solutions, Inc. portfolio CI
Frequently asked questions about Dehydrated Alcohol Injection, USP
What is Dehydrated Alcohol Injection, USP?
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What is Dehydrated Alcohol Injection, USP used for?
Who makes Dehydrated Alcohol Injection, USP?
Is Dehydrated Alcohol Injection, USP also known as anything else?
What drug class is Dehydrated Alcohol Injection, USP in?
What development phase is Dehydrated Alcohol Injection, USP in?
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Related
- Drug class: All Sclerosing agent / Ablative agent drugs
- Manufacturer: Ablative Solutions, Inc. — full pipeline
- Therapeutic area: All drugs in Oncology / Interventional Radiology
- Indication: Drugs for Percutaneous ablation of hepatocellular carcinoma
- Indication: Drugs for Ablation of benign and malignant liver lesions
- Also known as: Alcohol
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing